# K132407: Vital Signs Patch System (in Short VSP)

- Pathway: 510(k) (Traditional)
- Applicant: Lifewatch Technologies, Ltd.
- Decided: Dec 19, 2014 after 504 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033378: Vital Signs Monitor, Propaq LT, Welch Allyn Protocol, Inc. (2004) Summary page 4.
- K110015: Vitalsens, Aingeal, V-Pod, Intelesens Limited (2011) Summary page 4.
- K122046: Wrist Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K151835: Vital Signs Patch System (2016), 0 descendants of its own

## Indications for use
The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, non-invasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional.

Source page: https://510kreport.com/device/K132407
Methodology: https://510kreport.com/methodology